Jobs (Biotech & Pharmaceuticals)

GlaxoSmithKline
13Jan
R&D Process Development Chemist
GlaxoSmithKline

Your Responsibilities:: The Jurong Pilot Plant was set up in 2 to develop analytical and engineering science, chemistry and technology, allowing the delivery of commercially-viable products and manufacture of clinical trial supplies to demonstrate the safety and efficacy of new medicines in development. As a key member of the Process Development team, you will report directly to the Chemistry Manager. Key responsibilities: You will be responsible for the    Read more

rapid introduction of processes using novel chemistry from Synthetic Chemistry into the R&D Pilot Plant and from there into commercial manufacture, enabling a seamless technology transfer process. Evaluate early phase processes from Synthetic Chemistry from a manufacturing perspective to select and optimize the final route and to identify Design for Manufacture opportunitiesPlan and execute clinical supply campaigns in the R&D Pilot PlantLead validation and technology transfer to commercial manufacturing facility We are committed to the on-going professional development of our team, ensuring you maintain and enhance your skills. As such, there will be opportunities for you to develop your expertise in commercial scale up within a continuous process plant. GSK’s dedication to the wellbeing of our employees is reflected in the benefits we offer; including healthcare for yourself and dependents, performance related bonus, long term incentives and a host of other flexible offerings you can tailor to your own preferences. We also offer a range of employee health and wellbeing programs including our truly unique Partnership for Prevention program, a global commitment by GSK to provide all employees with up to 40 preventative healthcare services bringing to life our mission to: do more, feel better and live longer. At GSK we value diversity and treat all candidates equally. We aim to create an inclusive workplace where all employees feel engaged, supportive of one another, and know their work makes an important contribution. Why You? Basic qualifications:Good honours Degree in Chemistry with at least 1 years’ relevant experienceExperience of technology transfer from R&D to manufacturing scaleProven track record in process development and scale-upstrong focus on customer/quality & good interpersonal & communications skillsAble to work effectively in a global teamPreferred qualifications: PhD in a relevant area of organic chemistry

Illumina Singapore Pte Ltd
12Jan
Data Analyst
Illumina Singapore Pte Ltd

Do you want to make a difference? Illumina’s mission is to improve human health by unlocking the power of the genome. If that inspires you, let’s talk. We’ve built a culture fueled by innovation, collaboration and openness, and established ourselves as the global leader in DNA sequencing and array-based technologies. Our people and our technology change lives by driving advancements in life sciences, oncology, reproductive health, agriculture and    Read more

other emerging markets. Life at Illumina is about working with teammates who are deeply passionate about what we do, because we know that our work has the power to improve lives. We’re an established company with a track record of phenomenal growth. Just check out our investor events and presentations to learn about our financial accomplishments. Our growth isn’t just in financials, we’ve been busy hiring the best and the brightest. Perhaps that’s why MIT has ranked Illumina near the top of its World’s Smartest Companies each of the last three years. If you thrive in a brilliant, fast-paced, and mission-driven environment, Illumina is the place for you. Join the journey of a lifetime. Join Illumina.Position Summary:This position reports to Senior Manager of Production, and will work closely with Enterprise System Architect and Network Support group.The group manages the technology and applications that drives the manufacturing reporting and operation needs.The position requires at least 2 years of experience having completed at least 1 software development life cycle.You must have a working knowledge of relational databases, object-oriented programming in web and client-server concept. You must also be able to rely on experience and judgement to plan and accomplish goals.All About You Responsibilities:Provide technical expertise and recommendations in assessing new IT software projects and initiatives to support and enhance our existing Microsoft based systems.Identify opportunities that can improve efficiency of business processes.Investigate and resolve application functionality related issues and provide first level support.Manage application development for multiple projects.Assist in application installation and testing.Troubleshoot technical issues and identify modifications needed in existing applications to meet changing user.RequirementsDiploma/Degree in Computer Science or related discipline.Should have at least 2 years technical roles in software development preferably in web.Good background in C# web development but not restricted to using Microsoft .NET / ASP.NET / MVC / WCF / AJAX.  JavaScript / JQuery client-side scripting and Bootstrap / JQuery UI for components and styling.Database design in Microsoft SQL with ability to write and optimized queries or stored procedures.Experience with Version Management tool such as Microsoft Visual SourceSafe.Ability to develop mobile apps for phones / tablets would be advantageous.Knowledge of data processing, hardware platform and enterprise software applications.Ability to work independently as well as collaboratively as part of a highly-skilled team.Excellent communication skills possess logical and analytical skills with attention to detail.EducationDiploma/Degree in Computer Science or related discipline.Passion in software development and keen in writing or debugging software codes.Willing to learn and adopt coding practice to ensure system sustainability.Have done coding with .Net Framework using C#, would be desirable.Understand database schemas and design, ability to write queries or stored procedures, preferably with MS SQL.Experience in developing mobile apps for mobile devices would be advantageous.Excellent communication skills possess logical and analytical skills with attention to detail.Candidates with no experience may be considered.Illumina believes that everyone has the ability to make an impact, and we are proud to be an equal opportunity employer committed to providing employment opportunity regardless of sex, race, creed, color, gender, religion, marital status, domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, sexual orientation, pregnancy, military or veteran status, citizenship status, and genetic information.

Pfizer
11Jan
Senior Quality Assurance Manager (QC Support)
Pfizer

POSITION SUMMARY: Responsible for establishing & maintaining QA operational oversight for site Quality Control (QC) and assures overall quality/integrity of the chemical and microbiological laboratories to support the release and approval of Active Pharmaceutical Ingredient (API). The incumbent will be required to achieve the site quality assurance operational objectives by contributing information and analysis to the following areas: Quality Assurance (QA), plans and reviews: prepare and complete strategic    Read more

and ongoing action plans across all QC operational areas: Testing Operation; Quality Review; Systems & Instrumentation,Implement QC, productivity, quality, and customer-service standards,Establishes and maintains QA operational surveillance of QC operations and processes to insure compliance with established procedures and regulations,Coordinate within site and with relevant global Pfizer group/s with respect to implementation of Pfizer Quality Standards (PQS), policies and any other legislative requirements on site,Establish and provide the QC team with QA Compliance guidance and decisions,Provide support for the review/assessment and approval/implementation of deviations, laboratory investigations, change control and associated CAPA evaluation / CAPA closeout across QC operations,Establish, author, review and approve QA-related and functional area documentation and procedures,Reviews and QA approver for QC related specification and test method documentation associated with a given raw material, packaging material, in-process material and finished API product,Establish and coordinates and performs QC batch record disposition and release in SAP for finished API when and where required,Assures that all processes, systems, facilities, methodologies utilized in the testing of raw materials, in-process samples and finished API are validated and fully integrated,Reviews and approves QC method, equipment validation protocol and reports,Monitor Data Integrity (DI) initiatives and plans within QC and responsible for ensuring QC compliance with Pfizer DI expectations,In conjunction with the Quality Assurance Manager (Compliance) establish internal audit plans for QC and execute such plans and follow-ups thus meeting all Pfizer internal as well as regulatory requirements to ensure compliance to QC systems on site,Strive to continuously improve QC quality systems and practices on site with respect to achieving compliance, reducing waste and improving efficiencies,Support Operational Excellence (OPEX) programs and champion continuous quality improvement initiatives. The incumbent will be required to develop strategic and system action plans by conducting risk assessment, identifying critical control points and preventive measures, establishing critical limits, monitoring procedures, corrective actions, and verification procedures. The incumbent will ensure that the quality control systems, the products tested and Good Manufacturing Practice (GMP) related operations observe consistent compliance with cGMP, Pfizer Quality Standard (PQS) policies, site Standard Operating Procedures (SOPs) and regulatory guidance. The Incumbent will work with QA and QC to accomplish QC oversight objectives. The incumbent will have an excellent knowledge of cGMP, cGLP, cGAMP and knowledge of active pharmaceutical ingredient (API) manufacturing. The incumbent will interact with all departments on site and will need to be a self-starter with good interpersonal skills and excellent written and oral communication skills the incumbent will lead a team of QA professionals and will need to be action-orientated and a strong leader for the quality culture of the site. POSITION RESPONSIBILITIES:Responsibilities:Lead, direct and develop the Quality Assurance QC Support Team.Develop and communicate appropriate objectives, priorities and metrics for the team.Instigate a culture of lean operations by reviewing existing work practices and reducing non-value added activities in a systematic manner.Review and approve QC testing specification, QC testing methods operational instructions, change controls, deviations, laboratory investigation and stability reports as and when required,Enhance site QC staff’s knowledge of current Good Manufacturing Practice (cGMP); current regulatory requirements and general validation principles,In conjunction with the Quality Assurance Manager (Compliance) coordinate the site compendial monitoring review program and ensure QC compliance in line with global regulatory requirements,Ensure system is in place and QC complies with Data Integrity standards,Coordinate QC data input to Annual Product Reviews Reports (APRRs) when and where required,Coordinate QC Lead Time performance reviews when and where required,Develop meaningful quality KPI’s with the QC team and prepare and present trend reports for Quality Management Reviews and coordinate, develop and track QC Operations metrics,In conjunction with the Quality Assurance Manager (Validation & Vendor Management) ensure that appropriate systems are in place such that QC operations meet or exceed the requirements of the company and the regulatory authorities for the validation of QC Test Methods, QC equipment and QC software,Ensure current testing methods meet Pfizer internal standards and all pharmacopoeia requirements,Review and approve laboratory investigations and QC deviations and change controls when and where required,Support, promote and demonstrate corporate and Pfizer Global Supply (PGS) vision, values, and leader behaviors,Allocate department staffing and manage the utilization of facilities and equipment to ensure that departmental objectives are met,Conduct performance assessment and development reviews of staff as part of the department development efforts,In times of absence of other Quality Assurance Managers and, as directed by the Quality Operations Director from time to time, take up the responsibilities to cover other Quality Assurance Manager roles.Job Related Requirements:Demonstrated record of successful interaction with global regulatory agencies (e.g. FDA, HSA, MHRA) and other internal and external auditing groups.Successful track record of continuous improvement, development, and/or implementation of best practices in quality operations or manufacturing.Thorough knowledge and understanding cGMP, GAMP, validation principles, and applicable regulations related to validation principles.Thorough knowledge and understanding of the technical and commercial QC aspects of pharmaceutical API products.Excellent verbal, written and interpersonal communication skills.Demonstrated ability to interact effectively with senior management, auditors and regulators.Accountabilities:Team mentoring.QC input to Annual Product Review Report compliance.QC Lead Time Performance Review compliance.QC Deviations and laboratory investigations and CAPA effectiveness management compliance.QC Change Controls - impact assessment, approval and implementation of process changes and deviations compliance.QC Validation strategies, master plans and risk assessment compliance.QC Regulatory compliance.QC Internal Audit Program compliance.Problem solving.Staff maintenance and development.Performance evaluation.Key Performance Indicators (KPIs):Safety performance.Quality Control Operation Performance metrics.Metrics for closure of QC deviation and laboratory investigations and commitment tracking.Lead time for QC validation initiation and closure.QC Data Integrity plans and actions timeline adherence.Compliance to cGMP/cGLP/cGAMP requirements.ORGANIZATIONAL RELATIONSHIPS: The incumbent will interact with all site departments for GMP related operations and activities i.e. Manufacturing Operations Process Teams, Quality Control, Warehouse and Tank Farm teams and Engineering teams. In the event of quality or regulatory related issues, this position will interact with quality or regulatory representatives from drug product sites or Global Chemistry Manufacturing & Compliance (GCMC) teams. SUPERVISION:The incumbent is responsible for 1-3 direct reports.EDUCATION:Degree in Science / Engineering or related science.EXPERIENCE:Minimum 8 years of directly related experience in pharmaceutical manufacturing and quality operations, or equivalent combination of work experience and education.Related experience should be in GMP-regulated industries in Quality Control Operations, Quality Control Validation with Quality Systems knowledge such as Change Control, Deviation, CAPA and Documentation Management.Must have a working knowledge of FDA and ex-USA regulatory requirements as well as pharmaceutical industry quality systems.Must have an understanding of pharmaceutical industry trends and practices.Familiar with self-directed team concept, operations applications, six sigma, lean principles and process improvement tools.Minimum 5 years in a supervisory capacity.Experience in an API manufacturing plant is preferred.Related experience in at least two different pharmaceutical manufacturing facilities is preferred. Flexi Work - Tuas (Singapore) Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

Illumina Singapore Pte Ltd
11Jan
Buyer (6 months contract)
Illumina Singapore Pte Ltd

Do you want to make a difference? Illumina’s mission is to improve human health by unlocking the power of the genome. If that inspires you, let’s talk. We’ve built a culture fueled by innovation, collaboration and openness, and established ourselves as the global leader in DNA sequencing and array-based technologies. Our people and our technology change lives by driving advancements in life sciences, oncology, reproductive health, agriculture and    Read more

other emerging markets. Life at Illumina is about working with teammates who are deeply passionate about what we do, because we know that our work has the power to improve lives. We’re an established company with a track record of phenomenal growth. Just check out our investor events and presentations to learn about our financial accomplishments. Our growth isn’t just in financials, we’ve been busy hiring the best and the brightest. Perhaps that’s why MIT has ranked Illumina near the top of its World’s Smartest Companies each of the last three years. If you thrive in a brilliant, fast-paced, and mission-driven environment, Illumina is the place for you. Join the journey of a lifetime. Join Illumina.Position SummaryReviews, analyzes, and coordinates purchasing activities with manufacturing, planning and engineering departments to acquire inventory in a cost effective and timely manner.Main Responsibilities: Assists with purchase requisitions, purchase change orders and supplier quote requests under general instruction.Supports procurement business system data input and integrity.Participates in maximizing the procurement teams' changes, part parameters; quote table maintenance, supplier database information, error report analysis, and part number/supplier code information.Assist with cost analysis and volume planning for major commodities (e.g. materials, components, equipment and services).Works in accordance with and may help improve cost, schedule and scope of assigned subcontracts to negotiate highest quality at best value.May interact with suppliers and QA to resolve a variety of quality issues.All listed tasks and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional task and responsibilities.Requirements: 2+ years related experience.Strong language proficiency in English, Mandarins is required.Domestic or global expertise of assigned commodities preferred.Effective verbal and written communication, analytical and interpersonal skills.Strong organizational skills, detail oriented.Strong influencing and negotiating skills.Knowledge of ERP/MRP systems, word processing, spreadsheets, project management, etc. preferred.Knowledge of Microsoft Excel and Outlook required.Must be very detail oriented.Educational: Bachelor’s degree or equivalent required.Illumina believes that everyone has the ability to make an impact, and we are proud to be an equal opportunity employer committed to providing employment opportunity regardless of sex, race, creed, color, gender, religion, marital status, domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, sexual orientation, pregnancy, military or veteran status, citizenship status, and genetic information.

Illumina Singapore Pte Ltd
10Jan
Sr Engineer - Product Lifecycle (EE)
Illumina Singapore Pte Ltd

Do you want to make a difference? Illumina’s mission is to improve human health by unlocking the power of the genome. If that inspires you, let’s talk. We’ve built a culture fueled by innovation, collaboration and openness, and established ourselves as the global leader in DNA sequencing and array-based technologies. Our people and our technology change lives by driving advancements in life sciences, oncology, reproductive health, agriculture and    Read more

other emerging markets. Life at Illumina is about working with teammates who are deeply passionate about what we do, because we know that our work has the power to improve lives. We’re an established company with a track record of phenomenal growth. Just check out our investor events and presentations to learn about our financial accomplishments. Our growth isn’t just in financials, we’ve been busy hiring the best and the brightest. Perhaps that’s why MIT has ranked Illumina near the top of its World’s Smartest Companies each of the last three years. If you thrive in a brilliant, fast-paced, and mission-driven environment, Illumina is the place for you. Join the journey of a lifetime. Join Illumina.Basic Function and Scope of the Position:Responsible for supporting product transfer, instrument manufacturing, troubleshooting, failure analysis, quality improvement, process enhancement, cost reduction, engineering evaluation and system improvement. Tasks and Responsibilities:Support and drive activities to ensure successful product transfer into manufacturing.Drive troubleshooting, failure analysis, root cause analysis, issues closure and corrective action processes as required.Perform instrument setup, calibration and final system integration test.Establish and maintain databases of instrument failures and defects.Perform data trending analysis, construct and execute design of experiments to address yield and quality issues.Drive and implement process improvements and product sustaining activities to meet the production goals.Drive maintenance and improvement activities on test fixtures and equipment.Drive and implement cost reduction activities by perform engineering evaluation to qualify new or improved materials, processes and products.Apply various analysis techniques, such as FMEA and statistical analysis to optimize product quality and minimize cost, providing all calculations, performance data, and drawings required on new and existing products.Manage and coordinate Engineering Change Order implementation activities including scrap analysis, material disposition, update work instructions and test requirement changes.Documentation responsibilities include, but not limited to, generating detailed engineering drawings, Bill of Materials, test reports, assembly procedures and design validation plans.Work closely with contract manufacturing partners and key suppliers to ensure smooth transition of quality products from development into manufacturing.Provide guidance and supervision to junior staff.All listed tasks and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional tasks and responsibilities.Preferred Educational Background:Bachelor’s degree or Master in Electrical or Electronics Engineering. Preferred Experiential Background:5+ years of engineering experience in mechanical or electro-mechanical based products for commercial and industrial markets.Good working knowledge and experience in electronics, PCBA manufacturing and testing and electro-mechanical systems.Solid knowledge of PCBA design, ICT, FCT and standard manufacturing processes is essential.Strong organizational skills, attention to detail and accuracy, and the ability to work independently in a team environment are essential.Candidate must be able to effectively lead teams, interface well with the manufacturing and service organization, and has a proven track record of transferring products to manufacturing.Must possess good analytical and troubleshooting skills.Proficient in engineering tools such as, statistical analysis, design of experiments, product and process capability analysis.Proficient in ORCAD, Altium or other PCBA design tools.Experience with FDA regulated medical device product development preferred.Product development experience in the life sciences, biotech, biomedical, nanotechnology or semiconductor industries preferred.Illumina believes that everyone has the ability to make an impact, and we are proud to be an equal opportunity employer committed to providing employment opportunity regardless of sex, race, creed, color, gender, religion, marital status, domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, sexual orientation, pregnancy, military or veteran status, citizenship status, and genetic information.

Illumina Singapore Pte Ltd
10Jan
Sr Engineer - Product Lifecycle (SW/FW & Test Dev)
Illumina Singapore Pte Ltd

Do you want to make a difference? Illumina’s mission is to improve human health by unlocking the power of the genome. If that inspires you, let’s talk. We’ve built a culture fueled by innovation, collaboration and openness, and established ourselves as the global leader in DNA sequencing and array-based technologies. Our people and our technology change lives by driving advancements in life sciences, oncology, reproductive health, agriculture and    Read more

other emerging markets. Life at Illumina is about working with teammates who are deeply passionate about what we do, because we know that our work has the power to improve lives. We’re an established company with a track record of phenomenal growth. Just check out our investor events and presentations to learn about our financial accomplishments. Our growth isn’t just in financials, we’ve been busy hiring the best and the brightest. Perhaps that’s why MIT has ranked Illumina near the top of its World’s Smartest Companies each of the last three years. If you thrive in a brilliant, fast-paced, and mission-driven environment, Illumina is the place for you. Join the journey of a lifetime. Join Illumina.Basic Function and Scope of the Position:Responsible for supporting the test software development and sustaining activities in the production of Illumina’s genetic sequencing instrumentation.  Be the main LCM interface with firmware and software engineers from the design and development teams in Singapore, the US, and the UK to test and verify integrity and functionality.  The position will involve hands-on technical tasks involving all aspects of the product development process including design and analysis, test/integration/characterization, and generation of product and test documentation.Tasks and Responsibilities:Involve early and understand the design and integration of embedded firmware and software for cutting-edge genetic analysis instruments incorporating optics, fluidics, motion system, and advanced image sensors/camera.Work with the design team to gain familiarity with the development of firmware to support embedded systems in ARM environment using C/C++ for sensor data collection, motor/servo drive, temperature control, and UI.Support system-level testing and debugging of firmware and software issues during NPI prototype and Pilot builds on-site in Singapore.Work with other engineering disciplines (EE, ME, Optics, Systems) in the US and Singapore to develop test suites and debug embedded firmware and software issues.Follow best practices for software release control, conduct SW User Acceptance Test (UAT) and Defect Tracking.All listed tasks and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional task and responsibilities.Preferred Educational Background:BSEE or equivalent engineering degree. Preferred Experiential Background:Minimum 5 years’ experience developing embedded firmware for complex products, preferably scientific instrumentation related to biotech applications in C/++, preferable on ARM processorsExperience with embedded RTOSs such as ThreadX, LynxOS, QNX.Direct experience completing projects from early inception to release to manufacturing. Demonstrated track record for successfully transferring designs into manufacturing.Experience interfacing with imaging sensors and complex instrumentation a plus.Willingness to travel to US for extended stays while learning the technology and working with the US design teams.Expertise working with design partners in the US and local out-sourced CDM/ODMs. Proven ability to function with external design and manufacturing contractors in an ODM model.Illumina believes that everyone has the ability to make an impact, and we are proud to be an equal opportunity employer committed to providing employment opportunity regardless of sex, race, creed, color, gender, religion, marital status, domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, sexual orientation, pregnancy, military or veteran status, citizenship status, and genetic information.

Illumina Singapore Pte Ltd
10Jan
Sr Engineer, Product Lifecycle (ME)
Illumina Singapore Pte Ltd

Do you want to make a difference? Illumina’s mission is to improve human health by unlocking the power of the genome. If that inspires you, let’s talk. We’ve built a culture fueled by innovation, collaboration and openness, and established ourselves as the global leader in DNA sequencing and array-based technologies. Our people and our technology change lives by driving advancements in life sciences, oncology, reproductive health, agriculture and    Read more

other emerging markets. Life at Illumina is about working with teammates who are deeply passionate about what we do, because we know that our work has the power to improve lives. We’re an established company with a track record of phenomenal growth. Just check out our investor events and presentations to learn about our financial accomplishments. Our growth isn’t just in financials, we’ve been busy hiring the best and the brightest. Perhaps that’s why MIT has ranked Illumina near the top of its World’s Smartest Companies each of the last three years. If you thrive in a brilliant, fast-paced, and mission-driven environment, Illumina is the place for you. Join the journey of a lifetime. Join Illumina.Basic Function and Scope of the Position:Responsible for supporting product transfer, instrument manufacturing, troubleshooting, failure analysis, quality improvement, process enhancement, cost reduction, engineering evaluation and system improvement. Tasks and Responsibilities:Support and drive activities to ensure successful product transfer into manufacturing.Drive troubleshooting, failure analysis, root cause analysis, issues closure and corrective action processes as required.Perform instrument setup, calibration and final system integration test.Establish and maintain databases of instrument failures and defects.Perform data trending analysis, construct and execute design of experiments to address yield and quality issues.Drive and implement process improvements and product sustaining activities to meet the production goals.Drive maintenance and improvement activities on test fixtures and equipment.Drive and implement cost reduction activities by perform engineering evaluation to qualify new or improved materials, processes and products.Apply various analysis techniques, such as FMEA and statistical analysis to optimize product quality and minimize cost, providing all calculations, performance data, and drawings required on new and existing products.Manage and coordinate Engineering Change Order implementation activities including scrap analysis, material disposition, update work instructions and test requirement changes.Documentation responsibilities include, but not limited to, generating detailed engineering drawings, Bill of Materials, test reports, assembly procedures and design validation plans.Work closely with contract manufacturing partners and key suppliers to ensure smooth transition of quality products from development into manufacturing.Provide guidance and supervision to junior staff.All listed tasks and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional tasks and responsibilities.Preferred Educational Background:Bachelor’s degree or Master in Mechanical or Electro-mechanical Engineering.Preferred Experiential Background:5+ years of engineering experience in mechanical or electro-mechanical based products for commercial and industrial markets.Good working knowledge and experience in mechanism design and electro-mechanical systems.Strong organizational skills, attention to detail and accuracy, and the ability to work independently in a team environment are essential.Solid knowledge of GD&T, plastic & sheetmetal tooling, casting, mechanism, stress analysis, mechanics, machining and standard manufacturing processes.Candidate must be able to effectively lead teams, interface well with the manufacturing and service organization, and has a proven track record of transferring products to manufacturing.Must possess good analytical and troubleshooting skills.Proficient in engineering tools such as, statistical analysis, design of experiments, product and process capability analysis.Proficient in Solidworks or 3D CAD tools.Good working knowledge of BOM (Bill-Of-Material) structuring fundamentals and have the ability to create ECOs (Engineering Change Order) and Deviations.Demonstrated use and understanding of MRP systems, Product Data Management systems and Change Control processes. SAP & PLM experience will be added advantage.Experience with FDA regulated medical device product development preferred.Product development experience in the life sciences, biotech, biomedical, nanotechnology or semiconductor industries preferred.Illumina believes that everyone has the ability to make an impact, and we are proud to be an equal opportunity employer committed to providing employment opportunity regardless of sex, race, creed, color, gender, religion, marital status, domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, sexual orientation, pregnancy, military or veteran status, citizenship status, and genetic information.

GlaxoSmithKline
09Jan
R&D Process Development Chemist
GlaxoSmithKline

Your Responsibilities:: The Jurong Pilot Plant was set up in 2007 to develop analytical and engineering science, chemistry and technology, allowing the delivery of commercially-viable products and manufacture of clinical trial supplies to demonstrate the safety and efficacy of new medicines in development. As a key member of the Process Development team, you will report directly to the Chemistry Manager. Key responsibilities: You will be responsible for the    Read more

rapid introduction of processes using novel chemistry from Synthetic Chemistry into the R&D Pilot Plant and from there into commercial manufacture, enabling a seamless technology transfer process. Evaluate early phase processes from Synthetic Chemistry from a manufacturing perspective to select and optimize the final route and to identify Design for Manufacture opportunitiesPlan and execute clinical supply campaigns in the R&D Pilot PlantLead validation and technology transfer to commercial manufacturing facility We are committed to the on-going professional development of our team, ensuring you maintain and enhance your skills. As such, there will be opportunities for you to develop your expertise in commercial scale up within a continuous process plant. GSK’s dedication to the wellbeing of our employees is reflected in the benefits we offer; including healthcare for yourself and dependents, performance related bonus, long term incentives and a host of other flexible offerings you can tailor to your own preferences. We also offer a range of employee health and wellbeing programs including our truly unique Partnership for Prevention program, a global commitment by GSK to provide all employees with up to 40 preventative healthcare services bringing to life our mission to: do more, feel better and live longer. At GSK we value diversity and treat all candidates equally. We aim to create an inclusive workplace where all employees feel engaged, supportive of one another, and know their work makes an important contribution. If you would like to join us in innovating and inspiring changes in the industry, we urge you to apply. Closing date for applications: 24 January 2018 LI-GSKWhy You?Basic qualifications:Good honours Degree in Chemistry with at least 1 years’ relevant experienceExperience of technology transfer from R&D to manufacturing scaleProven track record in process development and scale-upstrong focus on customer/quality & good interpersonal & communications skillsAble to work effectively in a global teamPreferred qualifications: PhD in a relevant area of organic chemistry Why GSK?: GlaxoSmithKline (GSK) is a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. We have three global businesses that research, develop and manufacture innovative pharmaceutical medicines, vaccines and consumer healthcare products. Our goal is to be one of the world’s most innovative, best performing and trusted healthcare companies. We are proud of the difference we make. GSK has ranked 1st in the Access to Medicines Index all five times since its launch in 2008 and FORTUNE Magazine ranked us #1 on its ‘Change the World list’ which recognises companies that have made significant progress in sustainable, scalable approaches to addressing societal problems as part of their company strategy. GSK has been present in Asia for over 50 years. To better support Asia, we focus on developing talent to improve our ability to make the right decisions for healthcare professionals, patients and consumers across the region. GSK was the first pharmaceutical company to set up manufacturing operations in Singapore, growing to be one of GSK’s largest manufacturing centres outside of the UK. The Jurong facility manufactures 16 active pharmaceutical ingredients used in a variety of GSK prescription medicines for the treatment of respiratory, HIV, gastro-intestinal, allergy, anti-viral and neurological conditions. Contact information: You may apply for this position online by selecting the Apply now button. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

ACM Global Central Laboratory (Singapore) Pte Ltd
09Jan
Clinical Research Associate
ACM Global Central Laboratory (Singapore) Pte Ltd

As a top five CRO, we have worked on 100+ marketed drugs across several therapeutic areas and conducted the pivotal or supportive trials that led to FDA and/or international regulatory approval of 45+ such drugs. At PRA Health Sciences, providing innovative solutions for our clients is what we do. From full service clinical development to the pioneering Embedded SolutionsTM model, PRA provides a broad spectrum of solutions that meet    Read more

the demands of a diverse marketplace. At PRA, borders do not create boundaries. PRA’s success is dependent upon our ability to attract and retain a talented team of diverse professionals. Our growing workforce is comprised of over 11,000 employees, spanning 13 time zones across six continents and who speak more than 30 languages – yet operate in unison as one worldwide PRA community. Working fully outsourced to one of our global client, the Clinical Research Associate is ultimately responsible for the successful management of investigator sites throughout the site lifecycle, whilst working in accordance with ICH-GCP guidelines, the study protocol, applicable local and international regulatory requirements and internal Standard Operating Procedures. With full ownership of investigator sites for assigned studies, the Clinical Research Associate’s (CRA) involvement begins at site feasibility stage, with responsibility for the successful management of the site right through to close-out. In addition to planning and conducting various site visits (feasibility, site selection, interim and close-out) in accordance with the clinical monitoring plan, the Clinical Research Associate (CRA) fosters effective relationships with investigator site staff to ensure that key clinical metrics are met. This involves establishing innovative ways of increasing site and patient recruitment. When issues do occur, the Clinical Research Associate proactively and promptly implements corrective action plans, and, when applicable, escalates issues to more senior members of the study team. The Clinical Research Associate may also design and deliver training to site staff, when appropriate. The Clinical Research Associate (CRA) ensures integrity of clinical data through an ability to sufficiently maintain site tracking records and work diligently to relevant guidelines. Operating as a key part of a global study team, the CRA plays a fundamental role in our client’s drug development process. The successful candidate for this role will be able to demonstrate prior experience of working in investigator site management, including conducting monitoring visits, from either a pharmaceutical company or a CRO environment. Prior working knowledge of ICH-GCP guidelines and local and international regulatory requirements is essential. Fluency in English is an absolute requirement, as well as an ability to communicate effectively with others and manage your time effectively.

Shire
08Jan
Biotechnologist III
Shire

Primary Objectives of this Job With general supervision the individual will perform routine and critical manufacturing operations, including but not limited to work functions in Cell Culture and Purification areas. Operates production equipment according to Standard Operating Procedures (SOPs) for the production of commercial and/or clinical products. Responsibilities % of Time Job Function and Description 80%Primary responsibilities include:Execution of routine and critical production operationsLearn and perform well-defined    Read more

SOPsPursue on-the-job training through Competency Assessments to increase knowledge and understandingExecute instructions and record data in the Electronic Batch Management (EBM) system if applicableExecute instructions and record data in the Master Batch Records (MBRs) and Master Formulation Records (MFRs) if applicableAttain operating knowledge of the Process Control System (PCS)Record data into logbooks and log-sheetsReview logbooks and log-sheets dataPerform equipment monitoringPerform basic laboratory tasks including but not limited to sampling, pH and conductivity measurementsDemonstrate aseptic technique in the handling of product and materials if applicableTroubleshoot and resolve process related issuesInitiate and document production events in the Global Event Management System (GEMS) or equivalent systemPropose document revisionsComplete required training on timeCarry out work in a safe manner, notifying management of safety issues and risks10% The individual will manage equipment and support facility related projects by Perform scheduled cleaning of equipmentAssist in the assembly and disassembly of process equipmentPerform standardization of equipmentPerform basic 5S housekeepingInitiate Corrective Work Orders in the C3ME system or equivalent systemSupport change over activities10% Staff Technical Training and Development Meet and maintain training requirementsDevelop and maintain personal development planProvide annual performance self-assessment on development planResponsibility to adhere to any applicable EHS requirements.Commitment to a fair and respectful relationship to others and behavior in accordance with Shire’s Code of Conduct.Any other duties as assigned by supervisor.Education and Experience RequirementsDegree in Chemical Engineering / Bioengineering / Chemical & Biomolecular Engineering / Pharmaceutical Engineering or relatedDiploma in Applied Chemistry / Biomedical Sciences / Chemical Engineering / Food Science & Technology / Biologics & Process Technology / Chemical & Pharmaceutical Technology/ Food Science & Nutrition / Molecular Biotechnology / Biotechnology / Chemical & Biomolecular Engineering / Pharmacy Science or related and possess more than 2 years of relevant experience in the biotechnology or pharmaceutical industryNitec in Biotechnology / Chemical Process Technology or related with more than 5 years of relevant experience in the biotechnology, pharmaceutical industryMay be required to adjust work schedule to meet production demandsKey Skills and Competencies :May be required to perform as a subject matter expert for equipment and/or systemsAbility to following written instructions in the form of Electronic Batch Management (EBM), Batch Records (MBRs, MFRs) and Standard Operating Procedures (SOPs) where applicablePossess good communication skillsPossess good troubleshooting skillsFull awareness of current Good Manufacturing Practices (cGMP)Proficient documentation and proficient computer skillsProficient in aseptic technique where applicableAbility to wear personal protective equipment such as safety glasses/goggles, gloves and safety shoesAbility to gown and gain entry to biotechnology/pharmaceutical manufacturing areas.Ability to work in and out of 2-8 deg C Cold Rooms with appropriate personal protective equipment if requiredAbility to work in confined spaces if requiredAbility to work around chemicals (alcohols, acids & bases)